Atorvastatin in the Treatment of Mandibular Degree II Furcation Defects

NCT02386033 | Completed Phase 2 DMC

• 1 other identifier: GDCRI/ACM/PG/PhD/2/2013-2014AB
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

ABSTARCT Background: Atorvastatin is an inhibitor of 3-hydroxy-2-methyl-glutaryl coenzyme A reductase. Lately, it has shown to have anti-inflammatory and bone stimulatory effects. The aim of the current study is to explore the effectiveness of 1.2% atorvastatin (ATV) as an adjunct to scaling and root planning (SRP) in the treatment of mandibular degree II furcation defects. Method: A total of sixty subjects were randomly assigned to two treatment groups. 1. SRP plus placebo gel 2. SRP plus 1.2% ATV gel. Clinical parameters like probing depth (PD), relative vertical clinical attachment level (RVCAL) , relative horizontal clinical attachment level (RHCAL), modified sulcus bleeding index (mSBI) and site specific plaque index were recorded at baseline and then at 3, 6 and 9 months. The radiological assessment of bone defect fill was done at 6 and 9 months, using a computer-aided software.

Conditions

Chronic Periodontitis

Outcome Measures

Primary Outcomes (1)

• amount of bone fill

  baseline to 9 months

Secondary Outcomes (5)

• change in Relative vertical clinical attachment level

  baseline to 9 months

• change in RHCAL (relative horizontal clinical attachment level)

  baseline to 9 months

• change in probing depth

  baseline to 9 months

• change in site specific plaque index

  baseline to 9 months

• change in modified sulcus bleeding index

  baseline to 9 months

Study Arms (2)

SRP plus placebo

PLACEBO COMPARATOR

SRP was done for all the subjects. Placebo gel was delivered subgingivally into the pocket

Drug: Placebo Gel

SRP plus Atorvastatin

ACTIVE COMPARATOR

SRP was done for all the subjects. Atorvastatin was delivered in the pocket subgingivally

Drug: Atorvastatin (ATV)

Interventions

Atorvastatin (ATV) DRUG

After SRP, ATV gel was delivered subgingivally into the pocket

Also known as: ATV gel

SRP plus Atorvastatin

Placebo Gel DRUG

After SRP, placebo gel was delivered subgingivally into the pocket

SRP plus placebo

Eligibility Criteria

• Age: 30 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• lower first molars demonstrating a probing pocket depth of 5 mm and horizontal probing depth of 3 mm following phase 1 therapy, with furcation defects (degree II) present bucally in asymptomatic, vital lower first molars, with a furcation radiolucency on a periapical radiograph of the molars.

You may not qualify if:

• patients with systemic diseases like cardiovascular disease
• diabetes or HIV infection or on medications like corticosteroids which may impede the healing in periodontal tissues.
• pregnant/lactating females
• tobacco users
• alcoholics
• patients with unsatisfactory oral hygiene (plaque index greater than 1.5)
• teeth having gingival recession, caries involving pulp, intrabony defect present interproximally, grade 2/3 mobility
• Furthermore, patients allergic to ATV or other statins or those taking ATV/other statins systemically were excluded.

Sponsors & Collaborators

• Government Dental College and Research Institute, Bangalore: lead

MeSH Terms

Conditions

Chronic Periodontitis

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

Periodontitis; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and head, department of periodontics

Study Record Dates

• First Submitted: November 30, 2014
• First Posted: March 11, 2015
• Study Start: November 1, 2013
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: March 11, 2015

Record last verified: 2014-11